15 quality systems specialist jobs at 11 companies in Becker, MN
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Quality Systems Specialist
Eden Prairie, Minnesota, United States
$70k-$800k/yrOnsiteFull Time
Actus Nutrition: Produces nutritional ingredients for human and animal health
1+ YOEAssociate's degree required, bachelor's preferred; 1–3 years in quality assurance or quality systems support; working knowledge of FDA nutrition and standards of identity regulations.
IMRIS: Integrated intraoperative MRI solutions for advanced neurosurgical procedures.
5+ YOEBachelor's degree preferred; 5–8 years in quality assurance, quality systems, regulatory affairs, or a regulated industry, with CAPA, recall, audit, QMS, and medical device experience preferred.
Microsoft Office, Quality Management System (QMS), MDSAP
STERISNYSE: STE: Provides infection prevention and procedural healthcare products and services.
2+ YOEAssociate degree and 2 years of quality experience in a regulated industry, or high school diploma/GED and 6 years of experience. Manufacturing, quality systems, document control, and MS Office experience preferred.
Microsoft Office, Microsoft Excel, Microsoft PowerPoint, Propel, Windchill, SAP, ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, CAPA, NCR
Velosity: Manufacturer of precision medical components and assemblies.
2+ YOE3–5 years of quality experience preferred, including at least 2 years in plastic injection molding or equivalent; requires quality systems knowledge, Microsoft Office and IQMS experience, communication, problem-solving, and independent work.
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
5+ YOEBachelor's degree, 5+ years clinical QA experience including GCP audits, working knowledge of ISO 14155/13485/GCP/GMP/GDP, CAPA and quality systems experience, ability to travel up to 30%.
ISO 14155, ISO 13485, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Documentation Practice (GDP)
Dairy Farmers of America: Produces and distributes milk, cheese, butter, and dairy ingredients.
1+ YOEHigh school diploma, 1–3 years food manufacturing quality or food safety experience; familiarity with quality systems, record keeping, audits, and strong written/verbal English communication.
H2O Innovation: Provider of integrated water and wastewater treatment solutions and services.
Experience in document control and quality systems, strong Microsoft Office skills, knowledge of ISO 9001, willingness to travel up to 20%, and attention to detail for managing controlled documents and migrations.
Microsoft Word, Microsoft Excel, Microsoft SharePoint, Microsoft Outlook, Power Automate, Power Apps, Microsoft 365
Micro-Matics: Provider of custom precision-machined components and Swiss assemblies.
5+ YOEBachelor’s degree or equivalent experience, plus two-year post-education or five years of relevant experience. Requires ISO 13485 and AS9100 compliance knowledge, auditing, CAPA, document control, and quality-system administration.
TeleflexNYSE: TFX: Manufactures medical devices for critical care and surgical procedures.
5+ YOEBachelor's degree preferred and 5+ years in engineering document control, PLM, or change management within regulated medical devices. Requires PLM, ERP, and quality systems experience plus strong analytical and communication skills.
Product Lifecycle Management (PLM), Quality Management System (QMS), Enterprise Resource Planning (ERP), Oracle Agile, SAP S/4HANA/MDG, Windchill, Arena
Schneider ElectricEuronext Paris: SU: Provider of energy management and industrial automation solutions.
3+ YOEDeploy and commission electrical power monitoring systems; must have electrical and power quality knowledge, Modbus/Profibus/Bacnet experience, ability to travel, and valid US motor vehicle operation.
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
2+ YOECollege degree or equivalent experience, minimum 2 years supporting sales or service operations, experience with quality/business systems; SAP and SalesForce experience preferred.
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
2+ YOECollege degree or equivalent experience, minimum 2 years supporting sales/service operations, experience with quality and business systems; SAP and SalesForce experience preferred.
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
2+ YOECollege degree or equivalent, minimum 2 years supporting sales or service operations in medical device/regulated environments, experience with quality and business systems, SAP and SalesForce experience preferred.
Laborie: Manufacturer of specialized medical diagnostic and therapeutic equipment.
1+ YOEBachelor's degree in science/engineering,1-3 years regulatory affairs experience in medical device industry,experience with international registrations and quality system regulations,strong communication and organization skills.
Principal Regulatory Affairs Specialist – Vascular (on-site)
Saint Paul, Minnesota, United States
$87k-$173k/yrOnsiteFull Time
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
5+ YOEBachelor’s degree in a scientific discipline and regulatory submissions experience for medical devices, with knowledge of FDA, international regulations, quality systems, and clinical investigations; 5+ years preferred.
GTS, Quality Management Systems (QMS), Environmental Management Systems (EMS), word processing software, spreadsheet software, presentation graphic software